Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mobile hoists) Model/C...
FDA Device Recall #Z-1311-2026 — Class II — November 17, 2025
Recall Summary
| Recall Number | Z-1311-2026 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 17, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | ETAC A/S |
| Location | Gedved, N/A |
| Product Type | Devices |
| Quantity | 25 units |
Product Description
Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mobile hoists) Model/Catalog Number: 1430116,1430117,1430115 Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to an injury or disability. The device is designed for an individual lacking the ability to stand up and transfer themselves to / from a bed, the floor, a wheelchair, a chair, a toilet or similar due to reduced mobility or physical strength.
Reason for Recall
A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became clear that the defect occurs as a result of deformation of the materials involved between the lifting bar and the arm of the device. Such deformation can lead to limited mobility in the joint, which prevents proper functionality of the equipment.
Distribution Pattern
Worldwide - US Nationwide distribution in the state of PA and the countries of Australia, Czech Republic, Finland, France, Germany, Israel, Italy, Japan, New Zealand, Norway, Poland, Qatar Spain, Sweden, Switzerland, UK.
Lot / Code Information
(1) Model/Catalog Number: 1430116; UDI-DI: TBD; (2) Model/Catalog Number: 1430117; UDI-DI: TBD; (3) Model/Catalog Number: 1430115; UDI-DI: TBD;
Other Recalls from ETAC A/S
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1308-2026 | Class II | Brand Name: Molift Product Name: Molift Mover ... | Nov 17, 2025 |
| Z-1310-2026 | Class II | Brand Name: Molift Product Name: Molift 2-poin... | Nov 17, 2025 |
| Z-1309-2026 | Class II | Brand Name: Molift Product Name: Molift Mover ... | Nov 17, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.